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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:160729

Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.

Official recall number

Z-0388-2018

Evidence summary

Product code
JAK
Recall status
Terminated
Event initiated
November 10, 2017
Root cause
Under Investigation by firm
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0388-2018

Field note

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